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Application of the Visualization of Treatment Objective (VTO) Analyses in Fabricating Anterior Repositioning Splints

Primary Purpose

Temporomandibular Joint Disorders

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
therapeutic position of the anterior repositioning splints
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring temporomandibular Joint Anterior Disc Displacement, the visualization of treatment objective (VTO), anterior repositioning Splint

Eligibility Criteria

10 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • anterior disc displacement with reduction (ADDWR) confirmed by magnetic resonance imaging (MRI)
  • Classified as ASA 1 or 2
  • Willing to participate and sign a written informed consent form.

Exclusion Criteria:

  • pregnant women
  • heart pace disorders and epilepsy

Sites / Locations

  • Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

the therapeutic position of the ARS were determinded by the "minimum protrusive position"

the therapeutic position of the ARS were determinded by the VTO analyse

Arm Description

the therapeutic position of the ARS were determinded by the "minimum protrusive position",which was the traditional method to fabricate the anterior repositioning splints,the patients were instructed to protrusive the mandible in a therapeutic position in which the click is eliminated.

the therapeutic position of the ARS were determinded by the VTO analyse,first,the participants were constructed to take CBCT and MRI scans,the ideal therapeutic position of the ARS were located in which the temporomandibular joint space distribute well and the condylar recapture the disc,the dentist could determine the amount of condylar movement and performed VTO analyse by assessing the CBCT and MRI scans ,then it could easily realize the final condylar movements with the application of the dental articulator.

Outcomes

Primary Outcome Measures

temporomandibular joint function
the Craniomandibular Index (CMI) was used to assess the temporomandibular joint function after the inserted of the splints.

Secondary Outcome Measures

psychological assessment the PHQ-9
the PHQ-9 were used to assess the psychological factors in the baseline,1 month,2 and 3 months after the inserted of the splints.
psychological assessment GAD-7
GAD-7 were used to assess the psychological factors in the baseline,1 month,2 and 3 months after the inserted of the splints.
disc-condyle angle
the disc-condyle angle were measured through MRI scan
temporomandibular joint space
the temporomandibular joint space were calculated through CBCT scan

Full Information

First Posted
April 15, 2022
Last Updated
May 4, 2022
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05362201
Brief Title
Application of the Visualization of Treatment Objective (VTO) Analyses in Fabricating Anterior Repositioning Splints
Official Title
Application of the Visualization of Treatment Objective (VTO) Analyses in the Treatment of the Temporomandibular Joint Disc Displacement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study conducted a randomized controlled clinical trial to evaluate the effect of the the therapeutic position of the anterior repositioning splint determined by VTO analyse compared with traditional method for the treatment of the Anterior Disk Displacement with Reduction of the Temporomandibular Joint.
Detailed Description
A randomised clinical trial was conducted with 20 patients diagnosed with ADDWR through RDC/TMD and they were randomly allocated into the group 1(traditional group):the therapeutic position of the ARS were determinded by the "minimum protrusive position",which was the traditional method to fabricate the anterior repositioning splints;group2(digitial group): the therapeutic position of the ARS were determinded by the VTO analyse,first,the participants were constructed to take CBCT and MRI scans,the ideal therapeutic position of the ARS were located in which the temporomandibular joint space distribute well and the condylar recapture the disc,the dentist could determine the amount of condylar movement and performed VTO analyse by assessing the CBCT and MRI scans ,then it could easily realize the final condylar movements with the application of the dental articulator. They were followed-up in the baseline,1 month,2 and 3 months after the inserted of the splints using the Craniomandibular Index (CMI) for temporomandibular joint function and PHQ-9,GAD-7 for psychological assessments,the tmj space and disc-condylar angle were measured through the CBCT and MRI scans,before and after ARS therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
temporomandibular Joint Anterior Disc Displacement, the visualization of treatment objective (VTO), anterior repositioning Splint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomised clinical trial was conducted with 20 patients diagnosed with ADDWR through RDC/TMD and they were randomly allocated into the group 1(traditional group):the therapeutic position of the ARS were determinded by the "minimum protrusive position";group2(digitial group): the therapeutic position of the ARS were determinded by the VTO analyse.
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the therapeutic position of the ARS were determinded by the "minimum protrusive position"
Arm Type
Active Comparator
Arm Description
the therapeutic position of the ARS were determinded by the "minimum protrusive position",which was the traditional method to fabricate the anterior repositioning splints,the patients were instructed to protrusive the mandible in a therapeutic position in which the click is eliminated.
Arm Title
the therapeutic position of the ARS were determinded by the VTO analyse
Arm Type
Experimental
Arm Description
the therapeutic position of the ARS were determinded by the VTO analyse,first,the participants were constructed to take CBCT and MRI scans,the ideal therapeutic position of the ARS were located in which the temporomandibular joint space distribute well and the condylar recapture the disc,the dentist could determine the amount of condylar movement and performed VTO analyse by assessing the CBCT and MRI scans ,then it could easily realize the final condylar movements with the application of the dental articulator.
Intervention Type
Procedure
Intervention Name(s)
therapeutic position of the anterior repositioning splints
Intervention Description
the ADDWR paricipants will be allocated into 2 grounps and treated with anterior repositioning splints determined by traditional and digitial method respectively.
Primary Outcome Measure Information:
Title
temporomandibular joint function
Description
the Craniomandibular Index (CMI) was used to assess the temporomandibular joint function after the inserted of the splints.
Time Frame
up to three months
Secondary Outcome Measure Information:
Title
psychological assessment the PHQ-9
Description
the PHQ-9 were used to assess the psychological factors in the baseline,1 month,2 and 3 months after the inserted of the splints.
Time Frame
three months
Title
psychological assessment GAD-7
Description
GAD-7 were used to assess the psychological factors in the baseline,1 month,2 and 3 months after the inserted of the splints.
Time Frame
three months
Title
disc-condyle angle
Description
the disc-condyle angle were measured through MRI scan
Time Frame
three months
Title
temporomandibular joint space
Description
the temporomandibular joint space were calculated through CBCT scan
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: anterior disc displacement with reduction (ADDWR) confirmed by magnetic resonance imaging (MRI) Classified as ASA 1 or 2 Willing to participate and sign a written informed consent form. Exclusion Criteria: pregnant women heart pace disorders and epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HL Lin HL Lin
Phone
13599392799
Email
linhonglei@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Yu Hao Yu
Organizational Affiliation
Fujian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Yu, professor
Phone
18605916816
Email
kobegigi@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Application of the Visualization of Treatment Objective (VTO) Analyses in Fabricating Anterior Repositioning Splints

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